Stephanie Hawthorne, PhD
Research into 6 drugs scheduled to be presented during the upcoming 2016 ASCO Annual Meeting stand out as the most noteworthy abstracts on the docket this year because of their potential to influence clinical practice in the near future, according to Kantar Health, a leading healthcare and pharmaceutical industry advisory firm.
The list includes a novel chemotherapy compound for acute myeloid leukemia (AML), a first-in-class targeted agent for melanoma, and expanded findings about 2 checkpoint blockade immunotherapy drugs that have gained FDA approvals during the past 2 years.
More than 5200 abstracts have been selected for inclusion in the program for the annual meeting, which will be held June 3 to 7 in Chicago. Kantar Health’s “Top Presentations of Interest” were discussed by 3 experts who participated in an ASCO 2016 Preview webinar that the oncology information service OBR hosted last week. Other categories of interest were emerging research and later-stage disappointments.
“Our main driver to select this short list are those that are going to be able to have a near-term impact in the clinic,” said Stephanie Hawthorne, PhD, vice president of Clinical & Scientific Assessment at Kantar Health, during the OBR webinar. “That was a primary method—results with pivotal data that are going to lead either to a new market approval for a drug that’s not yet on that market or to a label expansion.”
Although most of the abstracts that will be presented are now available on the ASCO website, the findings reported in those documents represent older data gathered before the submission deadline in February, Michael King, managing director and senior biotechnology analyst at JMP Securities, noted during the OBR webinar. He cautioned that full data would be needed to reach conclusions about the research.
Listening to the full presentations to learn the “nuances” of the research being released is important for oncology specialists who look to the conference for practice-changing studies, agreed Lee S. Schwartzberg, MD, FACP, who offered a clinician’s view of the abstracts during the webinar. Schwartzberg is chief of Hematology Oncology at The University of Tennessee Health Science Center.
Here is a look at Kantar’s top 6 abstracts:
- CPX-351 (Vyxeos)—This chemotherapy agent is a liposomal formulation of cytarabine and daunorubicin that was tested among newly diagnosed, elderly patients (aged 60-75 years) with high-risk AML. The drug, developed by Celator Pharmaceuticals, is being evaluated for this patient population under the FDA’s breakthrough therapy program.
In a phase III trial, CPX-351 demonstrated median overall survival (OS) of nearly 9.6 months compared with 5.6 months for a cytarabine/anthracycline combination, for a 31% reduction in the risk of death (HR, 0.69; P = .005), according to the ASCO abstract. The analysts will be looking for more details about the toxicity profile and outcomes among patient subsets. Abstract 7000.
- Binimetinib (MEK162)—This oral small molecule is a MEK inhibitor being developed for patients with melanoma harboring an NRAS mutation, an aberration for which there currently are no targeted therapies. Array Biopharma plans to submit findings from the phase III NEMO trial to the FDA for approval in NRAS-positive melanoma this year.
In the study, binimetinib reached its primary endpoint of showing an improvement in progression-free survival (PFS), with a 2.8-month PFS for the novel compound in the intent-to-treat population compared with 1.5 months for dacarbazine (HR, 0.62; P <.001). Analysts will be looking for updated OS data. Abstract 9500.
- Daratumumab (Darzalex)—The CD38–targeting monoclonal antibody was granted an accelerated approval by the FDA in November 2015 for patients with multiple myeloma who have undergone ≥3 prior therapies. Results from the CASTOR study, one of the confirmatory trials required for full approval, are scheduled to be reported at ASCO.
The phase III randomized trial evaluated daratumumab in combination with the standard regimen of bortezomib (Velcade) plus dexathemasone among patients who had received at least 1 prior line of therapy. Janssen, which is developing daratumumab in collaboration with Genmab, announced in March that the study would be stopped early after meeting its primary endpoint for PFS (P <.0001). Abstract LBA4.
- Nivolumab (Opdivo)—The PD-1 inhibitor, approved thus far in 4 tumor types, is being evaluated under a breakthrough therapy designation in patients with squamous cell carcinoma of the head and neck (SCCHN). Updated results from the phase III CheckMate-141 trial will be presented at ASCO.